protecting canadians from unsafe drugs...

Protecting Canadians from Unsafe

Drugs Act

(Vanessa’s Law)

Chad Sheehy

Senior Regulatory Advisor

Inspectorate Program

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Introduction

• Canada regulates therapeutic products under Food and

Drugs Act.

• Regulatory requirements for safety, quality, and efficacy are

verified by product and establishment licensing, monitoring

and surveillance, and compliance and enforcement.

• Until recently, regulation focused largely on pre-market

activities, good manufacturing practices and adverse

reaction reports.

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Who was Vanessa?

“The introduction of Vanessa’s Law into the Canadian

Parliament feels something like justice because it will

prevent such tragedies from happening in other families.”

The Honourable Terrence Young, Member of Parliament

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Protecting Canadians from Unsafe Drugs Act

(Vanessa’s Law)

• Received Royal Assent on November 6, 2014.

• Represents the most profound and important

changes to Canada’s Food and Drugs Act in over 50

years.

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Vanessa’s Law - Objectives

To improve safety of therapeutic products by introducing

measures to:

• Strengthen oversight throughout the lifecycle of

therapeutic products

• Promote greater confidence in the oversight of

therapeutic products by increasing transparency

• Improve reporting of serious adverse drug reactions

and medical device incidents

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Outline

A. Scope and Definitions

B. Key Elements and Authorities

C. Regulation Making Authorities

D. Transparency Authorities

E. Coming into Force

F. Consultations

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A. Vanessa’s Law - Scope

• Definition of ‘device’ amended (combo, IVDDs)

• Applies to newly defined ‘therapeutic products’

• Includes prescription and over-the-counter drugs, vaccines,

gene therapies and medical devices

• Does not include natural health products

• New term ‘Therapeutic Product Authorization’

• Import, sale, advertisement, manufacture,

preparation, preservation, packaging, labelling,

storage or testing of a therapeutic product

• Includes valid or suspended licences

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Strengthening Oversight:

1. Power to Compel Information, Tests/Studies and

Reassessments

2. Power to Compel a Label Change

3. Power to Recall Unsafe Therapeutic Products

4. Tougher Measures for Failure to Comply

5. Ability to Incorporate by Reference

Improving Reporting of Serious ADR & Device Incidents

6. Mandatory reporting by Healthcare Institutions

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B. Vanessa’s Law – Key Elements

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1- Power to Compel Information

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Power to Compel Information

21.1 (1) If the Minister believes that a therapeutic product may present a

serious risk of injury to human health, the Minister may order a person to

provide the Minister with information that is in the person’s control and that

the Minister believes is necessary to determine whether the product

presents such a risk.

• Can be exercised against anyone the regulator believes has

information necessary to determine if a product poses a risk

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Power to Require Assessment

21.31 Subject to the regulations, the Minister may order the holder of a

therapeutic product authorization to conduct an assessment of the

therapeutic product to which the authorization relates and provide the

Minister with the results of the assessment.

Power to Require Tests or studies

21.32 Subject to the regulations, the Minister may, for the purpose of

obtaining additional information about a therapeutic product’s effects on

health or safety, order the holder of a therapeutic product authorization to

(a) compile information, conduct tests or studies or monitor experience in

respect of the therapeutic product; and

(b) provide the Minister with the information or the results of

the tests, studies or monitoring.

1- Power to Compel Information

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2- Power to Compel a Label Change

21.2 The Minister may, if he or she believes that doing so is necessary to

prevent injury to health, order the holder of a therapeutic product

authorization that authorizes the import or sale of a therapeutic product to

modify the product’s label or to modify or replace its package.

• Regulator can order a product or establishment licence holder to

make changes to a label or package to prevent injury

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3- Power to Recall Unsafe Therapeutic Products

21.3 (1) If the Minister believes that a therapeutic product presents a

serious or imminent risk of injury to health, he or she may order a person

who sells the product to:

(a) recall the product; or

(b) send the product, or cause it to be sent, to a place specified in the

order.

• New authority- with several unique aspects

• Corrective actions by user or owner may also be acceptable

• Authorization of sale with or without conditions is also possible

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Penalties & Fines- contravention

31.2 Subject to section 31.4, every person who contravenes any provision

of this Act or the regulations, as it relates to a therapeutic product, or

an order made under any of sections 21.1 to 21.3 is guilty of an

offence and liable

(a) on conviction by indictment, to a fine not exceeding $5,000,000 or to imprisonment for a

term not exceeding two years or to both; and

(b) on summary conviction, for a first offence, to a fine not exceeding $250,000 or to

imprisonment for a term not exceeding six months or to both and, for a subsequent

offence, to a fine not exceeding $500,000 or to imprisonment for a term not exceeding

18 months or to both.

• Modernization of penalties

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4- Tougher Measures for Failure to Comply

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Penalties & Fines- contravention

31.4 A person who contravenes section 21.6, or who knowingly or

recklessly causes a serious risk of injury to human health in

contravening another provision of this Act or the regulations, as it

relates to a therapeutic product, or an order made under any of

sections 21.1 to 21.3 is guilty of an offence and liable

(a) on conviction on indictment, to a fine the amount of which is at the discretion of the

court or to imprisonment for a term not exceeding five years or to both; and

(b) on summary conviction, for a first offence, to a fine not exceeding $500,000 or to

imprisonment for a term not exceeding 18 months or to both and, for a subsequent

offence, to a fine not exceeding $1,000,000 or to imprisonment for a term not exceeding

two years or to both.

• creates a new mens rea offence with substantially higher

penalties for knowingly or recklessly causing a serious

risk of injury to health in contravening the

Act, the regulations, or an Order


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Injunctions

21.5 (1) If, on the application of the Minister, it appears to a court of

competent jurisdiction that a person has done, is about to do or is likely

to do anything that constitutes or is directed toward the commission of

an offence under this Act in respect of a therapeutic product, the court may

issue an injunction ordering the person, who is to be named in the

application, to (a) refrain from doing anything that it appears to the court may constitute or be

directed toward the commission of the offence; or

(b) do anything that it appears to the court may prevent the commission of the

offence.

(2) No injunction is to be issued under subsection (1) unless 48 hours’

notice is served on the party or parties who are named in the

application or unless the urgency of the situation is such that

service of notice would not be in the public interest.

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5- Ability to Incorporate by Reference

30.5 (1) A regulation made under this Act with respect to a food or

therapeutic product and a marketing authorization may incorporate by

reference any document, regardless of its source, either as it exists on a

particular date or as it is amended from time to time.

• Permits technical and non-technical documents to be incorporated

into the Food and Drug Regulations by

• Simpler and less time-consuming process that does not require

regulatory amendment.

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6- Mandatory Reporting by Healthcare Institutions

21.8 A prescribed health care institution shall provide the Minister, within

the prescribed time and in the prescribed manner, with prescribed

information that is in its control about a serious adverse drug reaction

that involves a therapeutic product or a medical device incident that

involves a therapeutic product

• Regulations required for implementation

• Defining ‘serious ADR’ and ‘medical device incident’

• Prescribing anything that is to be prescribed in 28.1

• Before recommending Regs, Minister shall take into account

existing information management systems so as to not

impose unnecessary burdens

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Paragraph 30. (1.2)

(a) amendments, suspensions and revocations of therapeutic product

authorizations

(b) authorizing Minister to impose terms and conditions on licences,

including amendments

(c) safety information obtained through clinical trials (slide 22)

(d) authorization holders to provide Minister with information about risk,

or relevant to safety of the product

i. risks communicated outside of Canada

ii. changes to labelling outside of Canada

iii. recalls, reassessments and suspensions or revocations of

authorizations or licences outside of Canada

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(d.1) specifying business information under the Act that is not CBI, or

circumstances it ceases to become CBI

(d.2) authorizing Minister to disclose, without notifying the person whose

business or affairs it relates, or obtaining their consent, business

information that

i. is not CBI

ii. has ceased to be CBI

(e) respecting modification of labels and packages in 21.2

(f) recall of therapeutic products or sale of product subject to recall

(g) anything prescribed under 21.71 (slide 21)

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D. Vanessa’s Law- New Transparency Authorities

1. Public Disclosure of Health Canada Regulatory Actions

21.4 (2) The Minister shall ensure that any order made under any of

sections 21.1 to 21.32 is publicly available

• orders to compel information, label change, recall

• orders to conduct assessments, tests and studies

Also positive and negative decisions and rationales about

issuance, reassessment, license suspension/revocation and

terms and conditions

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2. Public Disclosure about Clinical Trials and Investigational Testing

21.71 The holder of a therapeutic product authorization referred to in

paragraph 30(1.2)(c) shall ensure that prescribed information concerning

the clinical trial or investigational test is made public within the prescribed

time and in the prescribed manner

• Therapeutic product authorization holders to make publicly

available information about clinical trials (for drugs) and

investigational testing (for medical devices)

• Regulations will specify how, where, when and what information

about clinical trials and investigational test an

authorization holders will have to make publicly

available

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3. Minister can Disclose Confidential Business Information about

Therapeutic Products

Disclosure- serious risk

21.1 (2) The Minister may disclose confidential business information

about a therapeutic product without notifying the person to whose

business or affairs the information relates or obtaining their consent, if the

Minister believes that the product may present a serious risk of injury to

human health.

• The risk doesn’t have to imminent

• Disclosure has to further a public safety or

health purpose

• Reflects what can be done now in common law

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“confidential business information” means- subject to regulations-

business information:

a) that is not publicly available,

b) the person has taken measures that are reasonable in the

circumstances to ensure that it remains not publicly available, and

c) actual or potential economic value to the person or their competitors;

disclosure would result in a material financial loss to the person or a

material financial gain to their competitors

• Authority to make Regulations that specify what isn’t CBI and

thus can be disclosed without consent


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Disclosure- health and safety

21.1 (3) The Minister may disclose confidential business information about

a therapeutic product without notifying the person to whose business or

affairs the information relates or obtaining their consent, if the purpose of

the disclosure is related to the protection or promotion of human health or

the safety of the public and the disclosure is to

(a) a government

(b) a person from whom the Minister seeks advice; or

(c) a person who carries out functions relating to the protection or

promotion of human health or the safety of the public.

• ‘Government’ is further defined • To someone carrying out functions re: health & safety • Reflect current common law


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Compel information (s. 21.1)

Direct label change/package modification (s. 21.2)

Recall unsafe therapeutic products (s. 21.3)

Incorporate by reference (s. 30.5)

Disclose confidential business information (s. 21(2) - 21(4))

Tougher fines and penalties (s. 31 – 31.4)

Seek a court order / Injunction (s. 21.5)

Make orders publicly available (obligation) (s.21.4(2))

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E. Coming In To Force- Upon Royal Assent

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• Order a reassessment (s. 21.31)

• Require tests and studies (s. 21.32)

• Attach terms and conditions to market authorizations (s.

30(1.2)(b))

• Therapeutic product authorization holders to register

clinical trials (s. 21.71) and provide new safety information

to Minister (s. 30(1.2)(d))

• Healthcare institutions to report serious adverse drug

reactions and medical device incidents (s. 21.8)

• Minister to disclose regulatory decisions and

rationales (s. 30(1.2)(b.1))

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E. Coming In To Force- Requiring Regulations

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• Consultation on the Amendments to the Food and Drugs

Act: March 25th - June 8th, 2015

• Scope

• The Minister's authority to require and disclose information

• The Minister's authority to order a label change/package

modification, and

• The Minister's authority to order a recall

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-

medic/consult_unsafedrugsact-guide-lesdroguesdangereuses-eng.php

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F. Consultations- Guide to New Authorities

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_unsafedrugsact-guide-lesdroguesdangereuses-eng.php













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• March 25th - May 25th 2015

• Scope:

• to assess information needs about therapeutic products taking into

account:

• Who is the end-user (e.g., patient, physician, government bodies);

• What information is required (and what is not);

• When should information be made available;

• How and from whom do end-users prefer to receive information

(method of access).

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F. Consultations- Transparency Needs-based Assessment

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-

medic/consult_unsafedrugsact-lesdroguesdangereuses-

eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_unsafedrugsact-lesdroguesdangereuses-eng.php











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Conclusion

“It is difficult to overstate the impact this bill will have for

Canadians who take prescription and over the counter

drugs. It represents a quantum leap forward in

protecting vulnerable patients and reducing serious

adverse drug reactions. It is absolutely necessary to

reduce deaths and injuries caused by adverse drug

reactions, seventy percent of which are preventable,

and will serve Canadians extremely well.”

The Honourable Terrence Young, Member of Parliament

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